Safety scalpel with blade retention

ABSTRACT

A surgical scalpel is presented which combines the attributes of cost-effectiveness in design and safety of single use scalpel devices and the ability to be autoclavable so as to promote the device as a multiple use device as well. The design of the device is such as to afford medical personnel the feel, weight and balance of the original metal unguarded scalpel, while maintaining safety through the shielding of the blade during non-use and the ability to dispose of the blade in a safe controlled manner. The user is able to remove the blade through the biasing action of a living hinge and have it securely attached to the shield of the device for later discharge into a sharps container, all without having to place ones hands near the unguarded sharp. The device to designed to use existing styles of blades currently available without needing costly inventories of specially created blades. This device is presented in several embodiments containing similar attributes for safety and discharge of the blade.

PRIOR APPLICATIONS CONTINUITY

This is a continuation of application Ser. No. 12/180,527 which wasfiled on Jul. 26, 2008 and is herein incorporated by reference in it'sentirety herein.

FIELD OF INVENTION

This invention covers the field of application where users are needingprotection from accidental punctures from scalpel blades during the useand storage of surgical scalpel. More importantly, it is the capture andremoval of the scalpel blades that is highlighted by this invention.

BACKGROUND OF INVENTION

Each year many users accidentally slice or puncture themselves withsharp instruments either during use, during transfer from one person toanother or from inadvertent misplacement of sharps in potentiallydangerous locations. This is especially dangerous in the medical arena,as potentially fatal diseases can be spread through accidental contactwith sharps. Emergency Rooms are battlegrounds compared to the operatingrooms where quick action amongst many people are required to save lives.Sharp protection is a must and must be easy to operate. Prior art isreplete with many different style of devices that act to cover sharpblades.

There are 4 main types of prior art that exists to prevent users fromaccidental contact with sharp blades. The 4 areas involve deviceswhere 1) the sharp is retracted into the body of the device, 2) wherethe device is a disposable or single use application, where the entiresharp with the handle is not reused, 3) a device that moves in anon-linear fashion to cover the blade while it is not in use, and 4)those devices which remove a detachable blade from the handle of thedevice.

In the first arena of prior art, patents have been granted for devicesmainly in the medical field. The basic premise for this group of patentsis that the blade is extended from and retracted back into, the handleof the device. There is usually one handed operation of these devices,but the Shapiro U.S. Pat. No. 5,571,128 issued on Nov. 5, 1996 disclosesa device that requires “rotary and longitudinal movement of the handle”to move the surgical element. That extra step of motion can be difficultif the surgeons hands are busy holding or manipulating another device.Most patents use devices that are similar in shape to existing scalpelsbut are machined or molded in such a manner to create a hollow in thebody of the scalpel to hold serve as a chamber to store the blade whilenot in use. The Dillion et al U.S. Pat. No. 5,730,751 and the Cote et alU.S. Pat. No. 5,431,672 detail this style of retracting blade into thebody prior art. Dillion provides for “an inoperative location within thehandle” and Cote states that the blade is slid from an “intermediateposition where the blade is within the handle”. Both Cote and Dillionprovide for the location of the triggering mechanism to retract theblade is nearest the distal or blade end of the device. Cote disclosesthe triggering mechanism on the side of the handle which could disturbthe surgeon as that is the natural position of the surgeons hand duringuse and possibly hinder the operation of the scalpel should it be usedin a tight surgical location such as under the arm or in persons withlayers of fat, where the scalpel is often used past the coetaneouslayers of the body. Both Cote and Dillion function only with theirrespective blades and handles are not transferable to current scalpelsin use. There are also issues present that would make the sterilizationafter use of these devices to be difficult if possible at all. U.S. Pat.No. 5,662,669 issued to Abidin et al on Sep. 2, 1997 discloses a highlycomplex internally retractable scalpel. As with most internallyretractable scalpels they would constitute single use as they are notautoclavable. With the complexity of the internal parts and springs,there are not adequate steam paths for cleaning. This makes for a veryexpensive single use application.

The second arena of prior art involves the use of single use blades andhandles. There are three main styles where the either the blade isretracted into the body, a shield is produced covering the blade orthere is a separable device that is used to cover the blade. In thefirst style, Dambal etal in U.S. Pat. No. 6,757,977 issued on Jul. 6,2004, Haining in U.S. Pat. No. 5,330,493 issued on Jul. 19, 1994 andU.S. Pat. No. 5,556,409 issued on Sep. 17, 1996, all disclose deviceswhere the blade is first extended for a single use and then is withdrawninto the body and some mechanism will prevent the blade from beingextended in the future. Thus making this device safe for disposal aftera single use. While Dambal and Haining uses a manual method, thumbpower, to retract the blade, Flumene et al in U.S. Pat. No. 6,022,364issued on Feb. 8, 2000, is “operated through an elastic returns means”.The second style involves the uses of a shield that moves over astationery blade. Wonderley in U.S. Pat. No. 5,417,704 issued on May 23,1995, discloses “a blade carried by the handle adjacent one end thereofand a guard movably mounted to the handle for sliding movement relativeto the handle between a protective position covering the blade and aretracted position exposing the blade.” Where Wonderley discloses amanual operation to move the shield into the desired position, Pilo etal in U.S. Pat. No. 6,589,258 issued on Jul. 8, 2003 discloses the useof an “elastic return elements to bring the blade back into theretracted inoperative position”. U.S. Pat. No. 7,153,317 to Kanodia etal issued on Dec. 26, 2006 discloses a typical inexpensive single usedevice where a shield slides over the handle exposing the sharps device.There is a positive lock preventing and visual indicia showing that thescalpel is not be reused. The third style as disclosed by Williams inU.S. Pat. No. 4,735,202 issued on Apr. 5, 1988, uses a separable shielddevice on a round handled scalpel that is removed and remounted afteruse. All of styles mentioned in this section involve the use of uniquesurgical handles and blades which are disposed of after use. This is anexpensive alternative as the majority of the cost of a normally usedscalpel is in the high precision surgically ground blade. It is noteconomically justifiable to use this method when medical costs areescalating very rapidly. Also the major problem with the single usestyle of scalpel is the lack of “feel” for surgeons. Metal handles havea balance and weight that the users are comfortable with and the singleuse style typically are much lighter and are tip-heavy versus handleheavy producing a different feel.

One issue with the aforementioned “single” use scalpels is the problemwith reuse. U.S. Pat. No. 7,346,989 issued to Shi on Mar. 25, 2008discloses (Col 1 Line 27) that scalpels available nowadays, however, canbe reused due to the deficiency of the configuration. Shi claims a“deadlock” recess that prevents the reusing of single use scalpel wherethe removal of the blade is not an option. This is an added cost thatreduces the cost efficiencies of using single use blades in the firstplace.

The third arena of sharps protection involve the use of a guard thatmoves to cover the sharp but does so in a non-linear path or motion.Landis et al in U.S. Pat. No. 5,843,107 issued on Dec. 1, 1998 andSchneider in U.S. Pat. No. 5,250,064 issued on Oct. 5, 1993 disclose ashield that is actuated by the surgeon's thumb, whereby a protectivemember is lifted away from the sharp during use. This presents severalissues; as the surgeon's thumb is not naturally located above the bladeduring or prior to use, the cover would present sight issues as it wouldbe in the line of sight of the surgeon during use, the cover wouldprohibit the use of the blade subcutaneously as is required in certainsurgical procedures or involving persons who are overweight and itrequires that the surgeon pay attention to something other than thepatient as the surgeon must be aware of holding the shield in position.Though both of these patents allow for use on existing sharps, itinvolves the placement of the devices next to the sharp where thereexist a large chance of accidental puncture. Capewell in U.S. Pat. No.5,478,346 issued on Dec. 26, 1995 also discloses a sharps guard but herethere is “a blade guard attached to the scalpel by a frangible tether”.Capewell uses a non-standard scalpel for this application and requiresthe user to move their fingers next to the sharp to operate this guard.This guard also contains the problems associated with the Landis andSchneider patents as well.

The fourth arena of the prior art involves the use of devices wherebythe sharp is attached to and then removed from the handle. In one group,there are those devices where the sharp is directly attached to thehandle and another group contains devices where the sharp is placed intoa cartridge which is then placed upon the handle. Both groups involvehandling of the sharp prior to it's inclusion into some protectivecover, increasing the chance of accidental puncture. In the first group,Herbert et al in U.S. Pat. No. 5,868,771 issued on Feb. 9, 1999, Newmanet al in U.S. Pat. No. 6,626,925 issued on Sep. 30, 2003 and van derWesthuizen et al in U.S. Pat. No. 5,330,494 disclose the procedure ofattaching the sharp to the handle and then attaching a sliding bladeguard. Once the sharp is used, the blade can be removed along with theguard. Herbert uses existing style surgical handles, while van derWesthuizen and Newman use a unique handle that is modified at the distalend of the handle nearest the sharp, to receive the guard. Both devicesrequire the user to load the sharps device onto the handle, requiringthe unguarded sharp to be handled by those that the device is designedto protect, and often those people are wearing gloves which will reducetactile feel. In a different approach disclosed by Noack in U.S. Pat.No. 5,312,429 issued on May 17, 1994, where a unique blade with anopposed tang is removed by sliding blade release element when theelement is slid down the handle toward the sharp. This is a two handedoperation involving two separate pieces. In the sliding of the element,if one's hand slips from the element it would be certainly by cut by theexposed blade. Also the blade is without direction or restraint whenreleased from it's location on the handle. It could fly anywhere in theoperating room as there is tension built up between the tang of theblade and the rest of the blade that was forced over the post on thehandle.

Cartridge types highlighted by U.S. Pat. No. 7,207,999 to Griffin et alissued on Apr. 24, 2007, show the use of a cartridge that contains theblade for the scalpel. The cartridge doubles as a shield when it isretracted over the handle after the attachment of the blade to the tangof the handle. Each cartridge is unique to a particular style of bladeand requires a two handed operation to remove and attach the blade. Thisextra cartridge material creates costly waste. It is also againstcurrent disposal regulations to mix plastics with metals sharpscontainers are they require different disposal techniques. U.S. Pat. No.7,172,611 issued to Harding et al on Feb. 6, 2007 shows anothercartridge but this one is required to use a special blade with“non-arcuate” holes which increase the cost and decreases it'seffectiveness to be used with a broad range of access. All cartridgestyle scalpels use the removal of the cartridge that contains the bladeas the means for blade removal. Though safe, these devices are limitedby needing unique cartridges to hold the wide variety of bladesavailable.

Another adaptation of this concept, which is closer to the currentinvention, is found the series of patents from Jolly et al, U.S. Pat.Nos. 5,827,309, 5,752,968 and 5,792,162 issued Oct. 27, 1998, May 19,1998 and Aug. 11, 1998 respectively. These Jolly patents show a bladeremover which first removes the tang of the blade from the post into anotch on the sliding guard. Then '968 discloses that “guard 30 can beadvanced distally to force blade 50 from blade carrier”. The built instresses mentioned above are now increased with a forcible removal ofthe blade with the sliding guard, increasing the chance for the blade tomisdirected about the operating room. In the second group, Gharibian inU.S. Pat. No. 5,527,329 issued on Jun. 18, 1996 and Cohn et al in U.S.Pat. No. 5,938,676 issued on Aug. 17, 1999 disclose the use of acartridge system whereby the sharp is placed into a cartridge which isthen encased by a guard prior to it's placement onto the handle. Thisoperation is safer as the sharp is guarded during assembly but creates asituation as each discloses a unique handle designed to receive thecartridges and shields. Cohn et al in U.S. Pat. No. 5,941,892 issued onAug. 24, 1999 combines prior art by incorporating the cartridge conceptthat is “removably retained within the cavity” in the handle. This is asafe alternative but uses unique handles. All of the prior art in thissection requires the use of two hands to safely operate the device whichis at odds with current FDA compliance rules.

In the last arena of prior art, a guard is placed around a stationeryblade. There is nothing unique about the concept, and it's applicationcan be seen from the simple to the complex. Applications of a morecomplex nature are found in Abidin et al in U.S. Pat. No. 5,662,669issued on Sep. 2, 1997 and U.S. Pat. No. 5,569,281 issued on Oct. 29,1996, Jolly et al in U.S. Pat. No. 5,741,289 issued on Apr. 21, 1998,Matwijcow in U.S. Pat. No. 5,207,696 and Dolgin et al in U.S. Pat. No.5,071,426 issued on Dec. 10, 1991. Matwijcow discloses a rack and pinionsystem for movement of the guard over the blade which causes a reversesequence of logic, as the user needs to pull back to move the guardforward. This could be confusing in the fast paced operating room whereseveral different type of devices might be used at once. Dolgin alsouses a “linkage system” to extend the blade guard “over a substantiallygreater distance than the distance which the surgeon's fingers move inoperating the actuating mechanism”. This is unnecessarily complex andexpensive concept using unique handles which requires manual loading ofthe blades onto the handle. Jolly provides for both linear actuation ofthe guard along with a rotational movement of the guard and blade awayfrom the handle for cleaning purposes. This device is complex andexpensive to manufacture and use. The Abidin '281 patent discloses aguard which “comprises an inverted U-shaped channel membertelescopically mounted within the hollow handle for sliding movementtherein”. It is held in position by exposed an exposed pin which wouldbe in the way of the surgeon's hands and could be accidentally triggeredto move at the improper time. This device is also not usable withcurrently used scalpels and it requires a unique handle. Abidin '669 isanother internally guided blade guard with a unique handle. But thispatent also discloses in column 10 line 11, that it does not work withconventional scalpel blades. '669 does combine a blade guard and a bladeejector, but FIG. 36 details the need for two handed operation to removethe blade. FIG. 45 and FIG. 48 show that the blade is not restrainedafter it is removed from the handle, and as described above, there is aconsiderable amount of tension on the blade. The disclosure details theadded tension as the guard actually pushes the blade off of the postupon which it is attached. There is nothing to restrain the loose blade.An unrestrained blade could fly off anywhere in the operating room andthis is not a safe method of removal. '669 also discloses in FIG. 32 thecomplicated way of attaching the blade with two small pins, which wouldbe very difficult with gloved hands in a hurried operating room. FIG.13D of '669 shows the user sliding the guard forward using theirforefinger, which would present an obvious problem should the guardbecome slippery due to bodily fluids, and the users finger slips fromthe guard onto the exposed blade.

There is a need to preclude the problems associated with the prior artand the current state of technology in this field. It would bepreferable to produce a device that would provide current users with adevice that would improve upon some of the shortcomings of the priorart. Industry has set standards for their equipment and it would bedesirable to have a device that fits their standard equipment, ratherthan adapt to new equipment. Sharps users, especially surgeons, are usedto the weight, balance, fit, form and feel of their tools of the trade,and are reticent to change. It is well practiced in the medical field,that metal sharps handles are used because they possess a certain weightand balance that plastic handles have a hard time replicating. Industryneeds to adapt protections to currently used sharps, as new device areusually meet with skepticism and doubt, and are thus not used. Industrydoes not want to carry duplicative inventories of many similar productsbecause they do not work with one another.

It would be desirable to have a new device be made in such a manner thatit would be reusable and manufacturable in great quantities, lowerproduct costs while assuring repetitive quality throughout the devicescould even make this product disposable after a single use. It would bedesirable to have the device made of autoclavable plastic or metal anddesigned so that it will not have any hidden recesses or other cavitiesthat would trap harmful bacteria precluding the chance that it could beautoclavable. It would be desirable and advantageous to possess a bladeremoving apparatus which is designed where the blade is held rather thanjust pushed off the blade post creating a more secure environment.

It would be desirable to have a scalpel to be able to be able to easilyremove and change blades during surgical procedures, whereby one handleis capable receiving multiple sizes and shapes of blades

BRIEF SUMMARY OF THE INVENTION

Accordingly, it is the goal of this invention to create a sharpsprotection device that has the aforementioned characteristics ofsimplicity, protection, adaptability to current uses and safety. It isan object of this invention to create a device that will protect boththe user of the sharp as well as the person who comes in accidentalcontact with misplaced sharps, and for the person to whom the sharp istransferred. It is also an object of this invention to create a devicewhich can be autoclavable should the user desire such re-usability yetbe cost-effectively designed to minimize cost to make single-use aneconomic reality.

Accordingly, it is the goal of this invention to create a sharpsprotection device that has the aforementioned characteristics ofsimplicity, protection, adaptability to current uses and safety for usewith scalpels. It is an object of this invention to create a device thatwill protect both the user of the sharp as well as the person who comesin accidental contact with misplaced scalpels, and for the person towhom scalpel is transferred.

It is an object of this invention to create a device that is operablewith a single hand and allows for the user to be either left or righthanded to operate the device. The user must be able to retract or extendthe sharps guard and be able to remove the sharp from the handle if thatoption is available to the user with the particular sharp.

It is an object of this invention to create a device that does notinterfere with the normal operation of the scalpel and that it does notsubstantially change the feel of the scalpel. It is an object of thisinvention to create a device whose design allows for the modification ofsaid design altering the weight and balance characteristics whilemaintaining overall design allowing for interchangability.

It is an object of this invention to create a device that is rapidlyinterchangeable between a wide range of sharp's blades. The device mustbe simple to use and maintain. Users must be able to disassemble, clean,and reassemble in a matter of moments, while using gloved hands withreduced tactile feel. The device must have no small or intricate partswhich would preclude the quick assembly of the device.

It is an object of this invention to create a device which adapts tocurrent state of the art devices, reducing the need for training,evaluating and maintaining multiple inventories of devices and sharps.It is an object of this invention that industry standard blades, whichare accepted onto a wide range of currently existing handles, are to beused without modification to the blade or handle.

It is an object of this invention to create a device which has positivestops, including tactual and auditory signals, indicating the relativeposition of the guard, either in retraction or extension of the surgicalsafety scalpel with blade retention.

It is an object of this invention to create a device that does notinvolve placing of the protective device over the sharp in such a mannerthat actually increases the likelihood of accidental contact with thesharp. The user should be able to use the device immediately “out of thebox” without having to add guarding or assemble cartridges prior to safeuse.

It is an object of this invention to create a device that will providefor safe removal of the sharp from the surgical safety scalpel withblade retention without the possibility unknown trajectories and whileusing only a single hand for the operation. It is a further object ofthis invention is to have the sharp blade covered during the time theusers hands are ejecting the blade, thereby reducing the chance foraccidental puncture

It would be desirable to create a device which is sterilizable, andcleanable without disassembly internal voids, sharp corners, chambers orholes which trap unsanitary material precluding the ability to easilyclean and sanitize the device through autoclaving or reuse of thedevice.

BRIEF DESCRIPTION OF THE DRAWINGS FIGURES

FIG. 1 is a detail side elevation of the scalpel handle

FIG. 2 details the shield that is used with the handle showing oneapproach to the attachment of the locking mechanism.

FIG. 3 details the shield that is used with the handle showing oneapproach to the attachment of the locking mechanism.

FIG. 4 is the combination of the shield on the handle in the rearmost oractive position.

FIG. 5 shows the use of the blade disengagement mechanism removing theblade from the tang.

FIG. 6 Shows the combination of the shield and handle in the closedposition.

FIG. 7 is a detail of the blade being removed from the tang

FIG. 8 shows the blade after removal from the tang as it is secure heldin place against the side wall of the shield.

FIG. 9 is a side elevation which details an embodiment of a handle wherethere is a top rail versus a side rail.

FIG. 10 is a frontal view showing the right side and top elevations ofthe single rail handle embodiments.

FIG. 11 is isometric view of the left side of an embodiment of theshield with a side button that functions with the single rail handle.

FIG. 12 is an isometric rearward oblique view of the shield with a sidebutton that functions with the single rail handle embodiment.

FIG. 13 is an upper view of another embodiment of a dual rail handle.

FIG. 14 is a detail view of the distal end of the dual rail handleembodiment.

FIG. 15 contains two views of an embodiment of a shield that interfaceswith the dual rail handle.

FIG. 16 details the operation of removing the blade from the bladeholder at an oblique angle for the shield embodiment of the single railhandle.

FIG. 17 detail of the removal of the blade from the blade holder from atop elevation for the shield embodiment of the single rail handle.

FIG. 18 details the total release of the blade from the blade holderbeing forced against the inner wall of shield from the single railhandle.

DETAILED DESCRIPTION OF THE DRAWING FIGURES AND INVENTION

The following detailed description of the drawing is provided to showthe enablement of the aforementioned principles in connection with thisinvention as it applies to the medical field, where surgeons, nurses andoperating room personnel, as well as emergency medical technicians andparamedics in the field, need protection from accidental puncture orlacerations from unguarded scalpel blades.

The hereinafter described invention can be used as a single use scalpelor as a multiple use scalpel. It is an object of this invention toprovide the user with this option and the components are designed withthe ability to be multi-use. This multi-use capability is developedthrough the use of steam channels, lack of hidden or reverse recessesand materials are that able to be sterilized in an autoclave. Thematerials used to construct this device can be metal or an autoclavableplastic such as the blend of polyphenylene oxide (PPO) and polystyrenedeveloped by General Electric sold under the trade name—Noryl. Singleuse versions can be made of a variety of plastics such as acrylonitrilebutadiene styrene (ABS) or Nylon, possibly containing a filler based onthe weight of the device desired.

FIG. 1 shows the left side elevation of the handle of the scalpel. Tangholder 110 is on the distal portion of handle 100, holder 110 containingtang slot 180. Immediately anterior to holder 110 along leading edge 101is shield engagement locator 162 which leads into engagement slot 161.Engagement slot 602 on shield lock 600 shown on FIG. 2 slides pastlocator 162 in a semi-depressed state into slot 161 meeting inclinedescarpment which is an engagement slope 163 causing the lock 600 toextended above the rest position. Three distinct sections are shown inFIG. 9 each comprising of a lead in escarpment and transitory sectionand a exiting escarpment as can been seen in blade ejectment section250, shield transitory section 251 and shield engagement stop 249. Afterpassing disengagement point 130, the lock 600 relaxes to it's restposition. This operation of attaching the shield can be done in thepresence of a blade 111 as seen in FIG. 6. The shield is in the forwardposition covering the blade and is held in place as engagement slot 602on shield lock 600 is held in place between the vertical faces offorward stop 131 and the distal vertical face 144 of travel rail 132.The shield locking mechanism controls the linear position of the shield.The lock is in it's natural state requiring positive displacement oflock 600 to move the shield distally or proximally. Travel slot 160defines the scope of travel of the shield as it traverses along thelongitudinal axis of the handle between the forward stop 131 and rearstop 133.

Upon depression of lock 600 by the user, motion rearwardly of the shieldexposes the blade as the shield is guided by travel slot 160 until slot602 contacts rear slope 147 of rear stop 133. This slope causes thenatural compression of the lock 600 giving the user tactile feel ofapproaching the rear extend of the shield displacement and providessupport to stop 133. Rearward slopes 147 and forward slope 143 providetactile feel to the user that they are approaching a stop. Prior to thatcontact with the slopes, slot 602 has minimal contact with the rail 132reducing friction. Further rearward progress guides the shield and slot602 into the rear engagement area 140, which is shown in FIG. 4, whichprovides a positive lock of the shield in the rearward position. Slot602 is securely held between the vertical face 141 of stop 133 and rearshelf 139. Travel slot 160 continues proximally into the upper steamslot 142 which allows for the transgression of steam along thelongitudinal axis of the handle during the autoclaving procedure.

Immediately anterior to holder 110 along trailing edge 102 as shown inFIG. 1 is the ejector bay 153. Bay 153 is defined by an ingress slope154 and ejector guide slope 150. Bay 153 serves as a guide for theejector pin that can remove the tang 113 of blade 111 from rear of bladeholder 112. While the user is pressing the ejector mechanism attached tothe shield, the user is also providing forward motion towards the distalend of handle 100 and bay 153 provides the centering and guidancenecessary to remove the tang. FIG. 5 shows the action of removing theblade from the tang holder which will be discussed later. Proximallylocated to Bay 153 is ejector wall 151 which separates the ejector bay153 from lower steam slot 152. The shape, length and contour of steamslot 152 is dictated by the weight and balance desired by the user priorto manufacturing. Steam slot 152 has a vertical component at theproximal end of the handle whereby steam is allowed to exit. The slotremoves excess material and thus cost, but also allows for steam to passthrough during the autoclaving process while the shield is in place. Itis an object of this invention to allow for sterilizing of the of theunit while it is together, preventing the need for extra operation andlost parts. Wall 151 serves as the tactile response to the usersignifying that the ejector mechanism is in place to begin the removalprocess. Ejector 665 has a rectangular shape and slot 152 is designed tobe narrower than the width of ejector 665 preventing the user fromengaging the ejector mechanism prior to it's introduction into bay 152.

FIGS. 2 and 3 detail the shields S1 and S2 that are basically similar inshape and function but have lock 600 facing in opposite fashions. Lock600 is attached to the upper portion of the shield 604. Shield isdefined as a 4 sided box shape with an exterior and matching interiorsides, having an upper portion 604 and a lower portion 605 along with aleft side 607 and a right side 606. The shape of the shield matches therectangular shape of the handle and is closely dimensioned to that ofthe handle to allow for minimal interference between the shield andhandle. The distal end 670 is curved and contains the ejector mechanismand access window shown on FIG. 3 and the proximal end containing thelocking mechanism 600 and blade number window 610. Window 610 isarranged so that in the closed position the industry standard locationof the number of the blade can be seen. This serves as a visual check toconfirm the correctness of the blade prior to the opening of a sterilepackage only to find the incorrect blade marked on the outside of thepackage and also serves as an identifier during surgery, where it ispossible to have several different scalpel blade sizes required during asingle operation.

Locking mechanism 600 is attached to upper portion 604 using livinghinge 612 to provide a pivot point through which mechanism operates,where height of the mechanism is controlled by length of adjustment 603and the mechanism pivots through the contoured opening defined bycontour edge 615 along the left side 607 of the shield. Shield S2 has asimilar contour 608 along the right side 606 to relieve the shield ofexcess unneeded material, and that configuration is also available onshield S1. Forward latch 601 protects the forward edge of the mechanismand provides a ledge to provide traction when raising the mechanismupwardly when removing the shield from the handle in the forwardposition over forward stop 131. The larger ledge allows for the use withgloved fingers while operating. Engagement slot 602 is held in aposition as to be parallel with the travel slot 160 at a distance frombutton 613 through the use of tab 611.

The distal end of the shield contains on one side the ejector mechanismand the other side either a viewing port 650 or a set of verticalbaffles (not shown) which is the preference of the user. In FIG. 3, theejector mechanism is shown on the left side to match the location ofejector bay 153 with which it interfaces. There is nothing limiting theejector mechanism being on the left side so long as the ejector bay 153matches it on the proper side. The ejector mechanism consists of livinghinge 662, extender 660, ejector flat 663, angled tang contact 664 andejector 665 all functioning through ejector window 666.

FIG. 5 shows the operation of removing the blade from the device. Thisdevice can be used as a single use scalpel where the user will place theshield in the closed position and discard of properly or the user canchose to remove the blade and place the unit in an autoclave forsterilization. The user with one hand, depressing the button 613,applies pressure moving the shield towards the closed position. The userbring the other hand and depresses ejector flat 663 until ejector isguided into the ejector bay 153, whereby the ejector 665 is directedinto a position behind and opposite of blade tang 113. Additionalmovement of the shield toward the distal end of the handle will causetang contact 664 to become flush with the tang 113. Due to the biasedelastic or spring nature of the design of the ejector mechanism, thetang of blade 113 will be eased off of the rear of blade holder 112.FIG. 7 details the interface between the ejector 665, contact 664 andblade 111. Further motion towards the distal end of the handle willremove the blade completely from blade holder 110. It is the predictableself-biasing nature of the convex design of the ejector mechanism, wherethe living hinge's natural tendency to remain open due to the materialstiffness properties of extender 660 and presence of material behind theliving hinge 662, that the ejector mechanism has the tendency to pullthe mechanism back to it's original position trapping the blade 111 init's path.

Blade 111 is now held securely to the inside wall of the shield due tothe spring nature of the design of the ejector mechanism. FIG. 8 showsthe blade held awaiting for the user to either again press the ejectorflat 663 and guide the sharp into a proper disposal means or to removethe shield by reversing the assembly steps and disposing of both theshield and blade into a disposal means.

It is critical to observe that it is the design of the steam vents andlack of interior voids that allows the device to be autoclavable withoutthe need to separate the shield from the handle. This design focuses onthe need to reduce extra handling and reduce the possibility ofaccidental sharps punctures by not exposing the sharp unless the userspecifically makes the effort to expose it. The device can be autoclavedin the open or closed position.

It is critical to observe that the ejector mechanism functions as aresult of the natural resistance of the shield material to change init's alignment, and that it is the high bending stiffness of thematerial that wants to return the ejector mechanism back to it's naturalstate that traps the blade against the shield. The design of livinghinge 662 and extender 660 and the material chosen are key components ofthe ability to hold the blade against the shield. Spring steel, stampedstainless steel and plastics with a low modulus of elasticity, whichincreases stiffness and memory and also has a high resistance to thermalstresses, such as polystyrene blends, nylon or polypropylene can beused.

FIG. 9 details an embodiment of the handle whereby the rail is locatedalong the top edge of the handle 200 rather than on the side as rail 160is located on handle 100. Handle 200 has a distal end which containsblade holder 210 where a blade is captured within blade rails 213 whichexist on the top and lower portions of blade holder 210. Rail 260 isdefined by side wall 261 and inner raceway wall 262. Inner raceway wall262 is also the platform upon which rests shield engagement stop 249,shield blade ejection section 250 and shield transitory section 251.

Side wall 261 defines the upper edge of handle 200 while lower shelf 230defines the lower edge of handle 200. Ejection area 221 immediatelysubjacent to blade holder 210 along shelf 230 can be either submergedinto the handle or on the same elevation as channel 220. Weight shelf233 will vary in height, dimension and contour as required by the userto mimic the feel and balance of pure metal scalpel currently in use anddesired by users. Channel 220 terminates into proximal area of handle200 at wall 204 where divot 202 is present to allow for the escape ofsteam during autoclaving.

Transitory section 251 provides the pathway along which the shield ridesduring the transition between the open and closed positions. Rear stop253 is provides the positive termination of the rearmost advancement ofthe shield. The shield pin 707 seen on FIG. 12, rests into the areabetween transitory beginning ramp point 240 and wall 204, when theshield is full open, providing an audible “click” as it is engaged and atactile “snap” as the pin relaxes into position, thereafter requiring apositive action to displace the shield from the rearmost position.Pressing button 706 removes pin 707 from rear stop 253 and over ramppoint 240 as the user provides displacement of the shield from therearmost or open position where the blade is fully uncovered to theclosed position after the pin 707 rides over end ramp point 241 andrests into closed position stop 242. Shield S3 rides along upperguidepath 245 providing some frictional resistance so that the user hassome control on the speed upon which the shield moves and a positivefeedback, auditory and tactile as the pin slides into shield close stop242. At this point the shield is closed protecting the blade. In thisembodiment, the user is free to reopen and use the scalpel as needed.

User wanting to remove the blade from handle 200, advances the shieldinto the shield ejection platform 246 by depressing button 706 andmoving the shield toward the distal end of the handle while pressing theejector button 763. Since the ejector button 763 is located distally andin close proximity to shield button 706, it is desirable for the userpress both with one hand or thumb enabling single hand use of theejector system. Ejector 765 slides behind blade tang 281 and is pushedoff of the rear of blade holder 212 after contact of tang 281 withejector flat wall 764. This is seen in the detail A of FIG. 16. ShieldS3 has come to a rest against shield engagement stop 249 where pin 707rests in ejector gap 247 where now blade 280 is trapped against theinside of shield wall 702 by the spring action of the ejector mechanismin FIG. 18 as detailed supra. The user has a tactile feel of thecompletion of this step as the slot raises causing the button to bedepressed then falling or snapping into gap 247. It is the predictableself-biasing nature of the design of the ejector mechanism, where theliving hinge's natural tendency to remain open due to the materialstiffness properties of extender 760 and presence of material behind theliving hinge 762, that the ejector mechanism has the tendency to pullthe mechanism back to it's original position trapping the blade 211 init's path.

User wanting to discharge the blade may do so in two ways. The user cansimply press button 763 while the distal end of handle 200 is placedover a sharps disposal container or user can disengage the shield fromthe handle completely disposing of both. The user depresses button 706until pin 707 completely clears shield engagement stop 249 and slidesthe shield distally over the empty blade holder 210 and disposes of theshield and blade properly. It is designed that the engagement stop willbe deeper than the other stops further encroaching into rail 260 topreclude accidental disengagement of the shield.

FIGS. 11 and 12 show detail views of shield S3 which has been adaptedfor handle 200. FIG. 11 is a view of the left side of the shield with adetail view of the button and ejector mechanism while FIG. 13 is a viewof the right side and bottom side of the shield and a detail view of theinterior of the button mechanism. This embodiment has two differentfeatures; one being the location of the engagement button mechanism tobe on the side vertical surface versus the top horizontal surface andthe relocation of the ejector mechanism to be next to the engagementbutton versus the distal end of the shield. Shield S3 has a largeviewing window 700 on either side so that the blade is visible to theoperator including the blade number. Button 706 is connected via livinghinge 706 which is designed to hold the button at an angle whereby thepin 707 is naturally located n the stop areas of the handle and isstressed while in the rail 260 of handle 200. Pin 707 due to the springaction of living hinge 706, frictionally rides along the travel rails245 and 246 giving positive feedback while pin 707 approaches railtermination slopes 240, 241, 243 and 244, whereby the user cananticipate the location of the shield as it moves. Shield button 706 hastexturing on the exterior, in this case louvers 708, which aids in thetactical feel of the button and the anti-slip attributes. Shield S3surrounds the handle with a box-like structure, having left and rightside walls, 702 and 703 respectively, encased by a top wall 701 andbottom wall 705. Pin 707 extends perpendicularly from button shelf 713as lower shelf 710 serves to maintain the rigidity of the buttonmechanism. Viewing window 700 can be replaced by louver style viewingslits 800, detailed in FIG. 15, on one or both sides. Ejector mechanismcomprising of living hinge 762, extender 760, button 763, ejector 765and flat 764 function through window 761 along left side 702 of shieldS3. A left handed operation, not shown, can be used in the reverse.

The operation to attach shield S3 to handle 200 is simply performed bydepression button 706 and guiding pin 707 into the rail 260 past thetermination platform 249 and releasing the button. The shield issecurely held in location within the rail for use. It should be notedthat the blade is covered during the operation of attaching shield S3onto handle 200.

Another embodiment of this invention is shown in FIGS. 13 and 14 whichinterface with shield S4 in FIG. 15. In this embodiment, shield S4 is aopen three sided or “C” shaped shield where the upper portion of the “C”has a perpendicular edge which serves as a guide which glides on thedual rail embodiment. This shield is designed for a single railinterface as well. FIG. 13 is a top oblique view of handle 300 whileFIG. 14 shows a detail of the distal end of handle 300. In thisembodiment, rail 360 has the purpose of containing pin 807 as itinteracts with platforms; termination 349, ejection 350 and transitory351. Shield guide post 814 interfaces with rail 380 which maintains thelongitudinal scope of travel. This single point of frictional interfacebetween the shield S4 and handle 300 reduces the amount of effortrequired to move the shield along the handle and reduces the amount ofplastic or other material in the construction of the shield S4. Assemblyof the shield S4 onto handle 300 consists of depressing button 806 andguiding pin 807 and post 814 into rails 360 and 380 respectively andreleasing the button as the user slides the shield past the terminationplatform 349. Shield S4 has a top 801 side terminates on the left sideinto left side of shield 802 and on the right side into a perpendicularledge that forms guide post 814. Shield S4 has a bottom component 805which is joined to left side 802 and right side edge wall 804 whichserves as a torsional stiffener for the shield. The height of wall 804is dependent upon the stiffness desired and the material selection.Distally, shield S4 has vertical louvers 800 which can be replaced asseen in FIG. 11 with a viewing window should the user desire thatconfiguration. There is also a blade number viewing portal 810 that canbe used to identify the blade number should it be hidden by the choiceof viewing windows. Ejection mechanism is located near the button 806 inorder to facilitate single handed operation of both and as previouslystated, all mechanism can be reversed along with wall 804 so that theejector mechanism and button are on the right side of the shield, andchanges to reverse the components on handle 300 will also beaccomplished. Ejector mechanism consists of living hinge 862 andextender 860 designed to be angled in order to take fullest advantage ofthe material's stiffness or elasticity attributes. The ejector mechanismfunctions through window 861.

Channel wall 370 separates rail 360 and rail 380 in the upper edge ofhandle 300. Rail 360 incorporates platforms; termination 349, ejection350 and transitory 351. Shield S4 is fully open when pin 807 is relaxedinto open position stop 352 which is bounded by proximal wall 304 andshield open slope 340. Operator will depress button 806 and physicallyrelocate the shield distally as post 814 rides in slot 380 and pin 807follows the upper guidepath 345 on transitory platform 351 until itreaches the shield close stop 341, whereby pin 807 rides up the slope ofstop 341 and releases into closed stop position 342. This action issimilar of the user wishes to open the shield, as the user will reversethe step allowing for pin 807 to follow the upper guidepath 345 untilthe pin rides up open shield slope 340 and releases into open positionstop 352.

As is noted on handle 300, channel 320 and shelf 333 are dimensioned andcontoured so that the feel, weight and balance of the scalpel is similarto that of existing scalpels. Each area may be built up or removed asshown in FIG. 14 where ejector channel 321 is shown as a relief cut intothe handle to lighten the front or blade end of handle 300, as it is notnecessary to have this relief for the ejector 865 if channel 320 isalready flush to the inside portion of the handle.

Ejection of the blade from the blade holder 310 is accomplished in asimilar fashion supra, as user advances the shield over the ejectorstart slope 342 onto ejector platform 350 on ejector guidepath 346 whilesimultaneously pressing ejector button 863 either with the same hand orthe opposite hand. FIGS. 16 and 17 detail the action taking place asejector 865 slides behind the blade and forward motion of the shieldcause ejector flat 864 to engage the rear portion of the tang of theblade and remove from the blade guide 313 on holder 310. As the useradvances shield S4 toward slot 347, the blade is removed and user has atactile feel of approaching the ejectment platform stop as the buttonbeing depressed naturally by the guiding of slot 807 over inclined slope344. Once in ejectment stop 347, the blade is removed it is immediatelysecured against the inside of the side wall 802 due to the biasedspring-like tendencies and attributes of the ejector mechanism. It isthe predictable self-biasing nature of the design of the ejectormechanism, where the living hinge's natural tendency to remain open dueto the material stiffness properties of extender 860 and presence ofmaterial behind the living hinge 862, that the ejector mechanism has thetendency to pull the mechanism back to it's original position trappingthe blade 311 in it's path.

User wanting to discharge the blade may do so in two ways. The user cansimply press button 863 while the distal end of handle 300 is placedover a sharps disposal container or user can disengage the shield fromthe handle completely disposing of both. The user depresses button 806until pin 807 completely clears shield engagement stop 349 and slidesthe shield distally over the empty blade holder 310 and disposes of theshield and blade properly. It is designed that the engagement stop 349will be deeper than the other stops further encroaching into rail 360 topreclude accidental disengagement of the shield.

It can be appreciated by those appropriately skilled in the art thatchanges, modifications or embodiments can be made to this inventionwithout departing from the spirit, principles, theories, ideas orconceptions that have been disclosed in the foregoing. It is hereinrecognized that the embodiments disclosed by this description of thebest mode of practicing this invention, which will be hereafterdescribed in their full breadth in the claims and equivalents thereof.

1. A surgical scalpel assembly comprising; a single piece handle, havingtwo vertical sides and two horizontal sides which terminates saidvertical sides, whereon a surgical scalpel sharps blade is capable ofsecure attachment at the distal end of said handle, said handle designedto have longitudinal travel channels and a separate longitudinal steamslot to allow for passage of sterilizing autoclave, said handle having alack of non-autoclavable interior voids, and having an ejector baylongitudinally positioned along one of said vertical sides at saiddistal end of said handle, and where at least one said longitudinaltravel channel is positioned along said horizontal side of said handle,and a shield, said shield having a substantially “C” shapedcross-sectional configuration having an interior and exterior portionand opposing upper and lower horizontal surfaces and a vertical surfaceconnecting to each said horizontal surface, said “C” shapedconfiguration capable of partial circumferential interface with saidhandle and where said upper horizontal surface contains a perpendicularedge to interface with said longitudinal travel channel of said handle,said shield having a distal end and a proximal end, containing asurgical sharps ejection mechanism located proximally along saidvertical surface, a shield locking mechanism interfacing with saidlongitudinal travel channel of said handle, and means to recognize theblade number of said surgical sharps, where said means to recognize theblade number of said surgical sharps is a section removed from saidshield so located as to allow the user to view the blade number of saidsurgical sharp while said shield is locked in said closed position, saidshield capable of linear transitory motion between fully covering saidattached surgical sharps blade in a closed position and fully uncoveringsaid attached surgical sharps blade in an open position, said shieldcapable of assembly and disassembly from said handle.
 2. A surgicalscalpel assembly as in claim 1 where said shield has four sides whosevertices form a rectangular cross-sectional configuration having aninterior and exterior portion and opposing vertical and horizontalsurfaces, capable of circumferentially interfacing with said handle andwhere said means to recognize the blade number of said surgical sharpsis a section removed from said shield so located as to allow the user toview the blade number of said surgical sharp while said shield is lockedin said closed position.
 3. A surgical scalpel assembly as in claim 1where said longitudinal steam slot allows for said handle and saidshield to be autoclaved whilst said shield is located thereupon saidhandle in either said open or said closed position.
 4. A surgicalscalpel assembly as in claim 1 where said shield is capable of linearmovement between said open and said closed position with using singlehand with locking button of said shield locking mechanism distallylocated away from users fingers during use of said scalpel.
 5. Asurgical scalpel assembly as in claim 1 where said shield lockingmechanism interfaces with one said longitudinal travel channel of saidhandle and has a longitudinal interface pin perpendicular to saidvertical surface of said shield.
 6. A surgical scalpel assembly as inclaim 1 where said shield locking mechanism interfaces with said travelchannel and has a longitudinal interface pin parallel to said verticalsurface of said shield, said pin in communication with said longitudinaltravel channel.
 7. A surgical scalpel assembly as in claim 1 where oneof said longitudinal travel channels contains three distinct separatesections, each section defined by lead in and exiting escarpments andstops, wherein one section is a blade ejectment section, wherein onesection is a forward closed shield securement area and wherein onesection is a rearward open shield securement area with tactile andauditory response to proper location therein each section and requiringpositive displacement perpendicular to said travel channel when saidshield is relocated therefrom.
 8. A surgical scalpel assembly as inclaim 1 wherein said ejector bay contains a blade ejectment securementarea with tactile and auditory response to proper location therewithinand requiring positive displacement of said shield to remove said bladefrom said distal end of said handle.
 9. A surgical scalpel assembly asin claim 1 where said shield locking mechanism has minimal frictionalcontact with said guide passageway during longitudinal linear movement.10. A surgical scalpel assembly as in claim 7 where said longitudinaltravel channel contains inclined tactile feel escarpments prior to andexiting from engagement of said shield locking mechanism into, and outof, said shield securement areas.
 11. A surgical scalpel assembly as inclaim 10 where said inclined escarpment at distal end of said bladeejectment area is linearly offset from other said escarpments to preventaccidental disengagement of said shield from said handle.
 12. A surgicalscalpel assembly as in claim 1 where said surgical sharp blade ejectormechanism while in the process of ejecting said sharps blade from saidhandle is deflected laterally by application of a load element, saidblade ejector mechanism possessing a self-biasing action to return saidblade ejector mechanism to a natural convex shape after ejecting saidblade from said handle through natural intrinsic exertion of maximumresistive forces to said resultant deflection, said resistive forcespreventing accidental dislodgement of said ejected blade from said bladeejector mechanism after ejecting said blade from said handle.
 13. Asurgical scalpel assembly as in claim 12 where said surgical sharp bladeejector mechanism is shaped to go behind blade, along ejector bay recessof said handle, said surgical sharp blade ejector mechanism laterallyremoving the tang of said blade from said distal end of said handle,said surgical sharp blade ejector mechanism solely using saidself-biasing action of said surgical sharp ejector mechanism.
 14. Asurgical scalpel assembly as in claim 13 where said removed blade ispositioned against interior portion of said shield and is prevented fromdisplacement due to said self-biasing action of said surgical sharpejector mechanism, said positioned blade being released by subjectingsaid surgical sharp ejector mechanism to a laterally applied load oncesaid surgical sharp assembly is located over a sharps containmentdisposal means.
 15. A surgical scalpel assembly as in claim 13 wheresaid removed blade is positioned against interior portion of said shieldand is prevented from displacement due to said self-biasing action ofsaid surgical sharp ejector mechanism, said shield and said positionedblade being able to be disposed of by removing said shield from saidhandle and disposing of said positioned blade and said shield into asharps containment disposal means.
 16. A surgical scalpel assembly as inclaim 1 where said longitudinal steam slot is volumetrically shaped tomaintain the balance and weight of industry standard scalpels.
 17. Asurgical scalpel assembly as in claim 1 where said means to recognizethe blade number is a set of louvers, located on at least one verticalsurface, said louvers having openings large enough to see the presenceor absence of said attached blade.
 18. A surgical scalpel assembly as inclaim 1 where said means to recognize the blade number is a windowopening, located on at least one vertical surface, said window openinglarge enough to see the presence or absence of said attached blade.